Idiopathic pulmonary fibrosis causes progressive morbidity and has a worldwide incidence that is increasing. There are a number of promising therapies, one of which has been approved in Europe, parts of Asia and India and others that are at various stages of development. Despite this there continues to be debate about the most appropriate clinical endpoint that should be used in future randomised controlled clinical trials of novel therapies in IPF. In a recent Perspective in the journal the case for the use of a variety of clinical endpoints was analysed and the article concluded that forced vital capacity, the endpoint most commonly used recently and in ongoing studies, was not an appropriate option. In this Perspective we present a counterpoint in which we explore the basis on which this conclusion is drawn and present data that strongly and logically support the use of forced vital capacity as a valid and robust measure that fulfils the criteria for an ideal clinical endpoint and that is meaningful to patient and clinician alike.

Idiopathic Pulmonary Fibrosis: Lung Function is a Clinically Meaningful Endpoint for Phase 3 Trials / Roland M., du Bois; Steven D., Nathan; Richeldi, Luca; Marvin I., Schwarz; Paul W., Noble. - In: AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE. - ISSN 1073-449X. - STAMPA. - 186:8(2012), pp. 712-715. [10.1164/rccm.201206-1010PP]

Idiopathic Pulmonary Fibrosis: Lung Function is a Clinically Meaningful Endpoint for Phase 3 Trials

RICHELDI, Luca;
2012

Abstract

Idiopathic pulmonary fibrosis causes progressive morbidity and has a worldwide incidence that is increasing. There are a number of promising therapies, one of which has been approved in Europe, parts of Asia and India and others that are at various stages of development. Despite this there continues to be debate about the most appropriate clinical endpoint that should be used in future randomised controlled clinical trials of novel therapies in IPF. In a recent Perspective in the journal the case for the use of a variety of clinical endpoints was analysed and the article concluded that forced vital capacity, the endpoint most commonly used recently and in ongoing studies, was not an appropriate option. In this Perspective we present a counterpoint in which we explore the basis on which this conclusion is drawn and present data that strongly and logically support the use of forced vital capacity as a valid and robust measure that fulfils the criteria for an ideal clinical endpoint and that is meaningful to patient and clinician alike.
2012
186
8
712
715
Idiopathic Pulmonary Fibrosis: Lung Function is a Clinically Meaningful Endpoint for Phase 3 Trials / Roland M., du Bois; Steven D., Nathan; Richeldi, Luca; Marvin I., Schwarz; Paul W., Noble. - In: AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE. - ISSN 1073-449X. - STAMPA. - 186:8(2012), pp. 712-715. [10.1164/rccm.201206-1010PP]
Roland M., du Bois; Steven D., Nathan; Richeldi, Luca; Marvin I., Schwarz; Paul W., Noble
File in questo prodotto:
Non ci sono file associati a questo prodotto.
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/747116
Citazioni
  • ???jsp.display-item.citation.pmc??? 30
  • Scopus 85
  • ???jsp.display-item.citation.isi??? 80
social impact